MAUDE Adverse Event Report: AV-TEMECULA-CT ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; BIORESORBABLE DRUG ELUTING SCAFFOLD

Catalog Number 1012463-18

Device Problem Difficult To Position (1467)

Patient Problem Perforation (2001)

Event Date 02/13/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: dil cath: nc sapphire 3.0x15, guide wire: bmw universal ii, guide cath: 6f jr4.The device was not returned for evaluation.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents from this lot.The reported patient effects of perforation, as listed in the bioresorbable vascular scaffold instructions for use is a known adverse event associated with the use of a coronary scaffold in native coronary arteries.The investigation determined the reported difficulties, patient effects and treatment appear to be related to circumstances of the procedure.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the us.

Event Description

It was reported that the procedure was to treat a lesion located in the mid circumflex (cx) with moderate calcification, mild tortuosity and 70% stenosis.Predilatation was performed with a 3.0x15mm non-abbott nc balloon catheter at 18 atmospheres (atm) but the balloon could not fully expand.The vessel diameter was estimated to be around 3.25mm with 120 degree calcification with intravascular ultrasound (ivus).Predilatation was performed again with a 3.0x15mm non-abbott balloon catheter at 22 atm.A 3.0x18mm absorb was implanted at 16 atm.Post-dilatation was performed with a 3.0x15mm non-abbott balloon catheter at 22 atm with 20% residual stenosis.Post-dilatation was performed again this time with a 3.5x8mm non-abbott balloon catheter at 18 atm.At the same time, a perforation was noted in the implant site of the absorb scaffold.A 3.0x18mm xience xpedition was advanced for treatment of the perforation; however, it could not cross the absorb scaffold even with a guideliner.Post-dilatation was performed with a 3.0x18mm non-abbott balloon catheter and a 3.0x16mm non-abbott stent was implanted for treatment of the perforation.The patient received protamine 4000 units and was transferred to the intensive care unit for observation.The patient was transferred to the general ward the next day.The patient is in stable condition.Reportedly, there was a clinically significant delay in procedure.No additional information was provided.

• Brand Name: ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Type of Device: BIORESORBABLE DRUG ELUTING SCAFFOLD
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6354490
• MDR Text Key: 68208895
• Report Number: 2024168-2017-01471
• Device Sequence Number: 1
• Product Code: PNY
• UDI-Device Identifier: 08717648157028
• UDI-Public: (01)08717648157028(17)170301(10)603026B
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/23/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2017
• Device Catalogue Number: 1012463-18
• Device Lot Number: 603026B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2017
• Initial Date FDA Received: 02/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2016
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 30