MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTALINK PLUS; CATHETER, CORONARY, ATHERECTOMY

Model Number 3241

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Obstruction/Occlusion (2422)

Event Date 05/01/2022

Event Type  Injury  

Manufacturer Narrative

B3: date of event: date of event was estimated since the event date was not reported in the journal article.Lin, jiunn-wen, et.Al., "rescue by retrograde techniques after rotational atherectomy in false lumen" j taiwan cardiovasc interv, 2023;14: 95-102.

Event Description

It was reported via journal article that false lumen occurred.The patient presented to hospital with intermittent effort angina and exertional dyspnea, ongoing for months.The myocardial perfusion imaging with non-boston scientific (non-bsc) imaging revealed stress-induced myocardial ischemia in the apical and inferior wall.Coronary angiography revealed significant stenosis in the proximal left descending artery (lad), total occlusion in the obtuse marginal branch of the left circumflex artery (lcx) and severe stenosis in the middle segment of the right coronary artery (rca).Coronary artery bypass grafting (cabg) was recommended but the patient declined.The patient went to another hospital for percutaneous coronary intervention (pci).The operator at the other hospital attempted to open the rca first.The rca was engaged with a 7 fr kimny guiding catheter.The operator attempted to cross antegradely using several guidewires including non-bsc guidewires with the support of a non-bsc microcatheter but was unsuccessful.Finally, another non-bsc guidewire reached the true lumen of the distal rca, as confirmed by contralateral injection.However, the operator encountered difficulty delivering equipment to the distal rca.Despite the use of a non-bsc guide-extension catheter, none of the available microcatheters and small balloons could be passed through the lesion.The operator decided for rotational atherectomy.After much effort, the physician finally succeeded in positioning a rotawire in the distal rca.The rotablation was performed with a 1.25 mm rotablator burr at 180,000 rpm.However, after the burr passed through the lesion, the distal flow was not restored.The operator noted extensive subintima tracking by the rotawire from the middle rca to the crus, whereby the rotablation was performed entirely within subintima space.The distal flow was completely obstructed as a result of the subintimal rotablation, which expanded the subintima space and compressed the true lumen.The procedure was hence stopped.Weeks later, the patient still suffered symptoms of effort angina, so the patient came to first hospital for a second attempt.Follow-up coronary angiography revealed that a huge false lumen from the middle rca to both the posterior descending artery (pda) and the posterolateral (pl) branches compressed the true lumen, almost obstructing the antegrade flow.A retrograde rescue intervention was decided upon.Multiple non-bsc devices were used to establish left to the right femoral access sites.Following serial balloon dilatations of varying sizes, a non-bsc intravascular ultrasound (ivus) catheter was deployed, which revealed huge intramural hematoma (imh) from the middle to the distal rca.Antegrade dilatation was followed by implantation of two non-bsc drug-eluting stents.The final rca angiogram demonstrated antegrade timi 3 flow with preserved pda and pl branch patency.The patient was discharged home after 2 days and did not report any further symptoms 12 months after the procedure.

• Brand Name: ROTALINK PLUS
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18852617
• MDR Text Key: 337071025
• Report Number: 2124215-2024-13430
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729316411
• UDI-Public: 08714729316411
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 6F GUIDE-EXTENSION -VASCULAR SOLUTIONS.; FIELDER FC GUIDEWIRE -ASAHI.; FIELDER XTA GUIDEWIRE -ASAHI.; FINECROSS MICROCATHETER -TERUMO.; SION BLACK GUIDEWIRE -ASAHI.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Male