MAUDE Adverse Event Report: AV-TEMECULA-CT ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; BIORESORBABLE DRUG ELUTING SCAFFOLD

Model Number	1235350-23
Health Effect - Clinical Codes	Angina (1710); Thrombosis (2100)
Date of Event	02/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The scaffold remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The 4.0 x 12 xience alpine referenced in b5 is being filed under a separate medwatch report number.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the us.
Event or Problem Description
It was reported that the procedure was to treat a proximal circumflex artery into the first marginal.The patient came in to the hospital on (b)(6) 2017 for a routine check-up.Optical coherence tomography (oct) was used throughout the procedure.The vessel was determined to be greater than 2.5 mm.A rotoblader was used and multiple unspecified balloons were used for pre-dilatation.The residual stenosis was reduced to less than 40%.A 3.5 x 23 mm absorb scaffold was implanted; however, the center of the scaffold recoiled, so a 4.0 x 12 mm xience alpine stent was deployed over the scaffold for a bail-out and it also recoiled.Post-dilatation was performed with a nc trek balloon catheter.The final angiographic residual stenosis was 40-50%.Oct confirmed that the scaffold and stent were fully apposed to the vessel wall.On (b)(6) 2017, the patient returned with chest discomfort and thrombosis was observed in both the scaffold and the stent and into the marginal artery.Balloon angioplasty was performed to regain flow to the arteries.The patient had been on plavix and aspirin and the dual antiplatelet therapy (dapt) medication was changed to brilinta.The patient is stable.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).The device was not returned for evaluation.A cine was received and reviewed by an abbott vascular physician.The reviewer concluded there was a severely under-expanded absorb scaffold due to highly resistant in-stent restenosis (isr) lesion in a calcified vessel, requiring placement of another metallic drug eluting stent (des) (xience) on top of the scaffold.The final result continued to show poor expansion by angiogram and optical coherence tomography (oct) showed final mld of less than 2.5mm.The thrombosis event occurring 5 days post procedure is most likely due to the under expansion of the lesion by the scaffold and metallic des.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 similar incidents from this lot.The reported patient effects of angina and thrombosis, as listed in the absorb gt1 instructions for use are known adverse events associated with the use of a coronary scaffold in native coronary arteries.Based on the information reviewed, the reported difficulty to deploy appears to be related to the circumstances of the procedure; however a conclusive cause for the reported patient effects cannot be determined.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Common Device Name: BIORESORBABLE DRUG ELUTING SCAFFOLD
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6432168
• Report Number: 2024168-2017-02492
• Device Sequence Number: 783322
• Product Code: PNY
• UDI-Device Identifier: 08717648213137
• UDI-Public: (01)08717648213137(17)170808(10)6080961
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P150023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/08/2017
• Device Model Number: 1235350-23
• Device Catalogue Number: 1235350-23
• Device Lot Number: 6080961
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/27/2017
• Supplement Date Received by Manufacturer: 07/18/2017
• Initial Report FDA Received Date: 03/24/2017
• Supplement Report FDA Received Date: 07/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STENT: XIENCE ALPINE 4.0X12
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention